Education & Outreach Archived Materials
- Overview of the NPRM (approx. 34 mins.), Jerry Menikoff, Director, OHRP
Watch: Overview of the NPRM
- Exclusions and Exemptions (approx. 30 mins.), Jerry Menikoff, Director, OHRP
Watch: Exclusions and Exemptions
- Informed Consent (approx. 28 mins.), Jerry Menikoff, Director, OHRP
Watch: Informed Consent
- IRB Review and Operations (approx. 18 mins.), Julia Gorey, Policy Analyst, Division of Policy and Assurances, OHRP
Watch: IRB Review and Operations
- Research with Biospecimens (approx. 22 mins.), Julie Kaneshiro, Deputy Director, OHRP
Watch: Research with Biospecimens
- Secondary Research Use of Data (approx. 21 mins.), Ivor Pritchard, Senior Advisor to the Director, OHRP
Watch: Secondary Research Use of Data
This collection includes early online training modules developed by OHRP that cover foundational information about the HHS regulations for the protection of human subjects in research.
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Description: The 1993 Guidebook was designed to assist IRB members, researchers, and institutional administrators in fulfilling their responsibilities to protect the rights and welfare of human subjects as defined in the HHS regulations (45 CFR 46). The Guidebook is not designed to tell IRBs whether or not specific protocols should be approved, however, it does point out issues to which IRBs should pay attention and, wherever possible, presents areas where ethicists and others concerned with these issues have arrived at a consensus on the ethical acceptability of a particular activity or method. The Guidebook includes regulations and policies, relevant institutional documents, text dealing with specific topics, a glossary of terms, and a bibliography.
Note: The IRB Guidebook was last updated in 1993. Developments over the intervening years have made portions of the Guidebook information obsolete, while portions of the information remain valid. There is no errata document to indicate which information has been superseded. OHRP cautions users to verify the current validity of any Guidebook information before relying on the information in a program of human subjects protection.
Content last reviewed on March 5, 2016